Pembrolizumab receives accelerated approval from the FDA for HER2-positive gastric cancer

Share This Post

August 2021: Pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine-, and platinum-containing chemotherapy has been granted accelerated approval by the Food and Drug Administration for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The KEYNOTE-811 (NCT03615326) trial, a multicenter, randomised, double-blind, placebo-controlled trial in patients with HER2 positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who had not previously received systemic therapy for metastatic disease, received approval based on a prespecified interim analysis of the first 264 patients. Pembrolizumab 200 mg or placebo was given to patients every three weeks in conjunction with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin.

The overall response rate (ORR) was the primary efficacy metric used in this study, which was examined by a blinded independent review committee. The ORR in the pembrolizumab arm was 74 percent (95 percent CI 66, 82) and in the placebo arm was 52 percent (95 percent CI 43, 61) (one-sided p-value 0.0001, statistically significant). The median duration of response (DoR) for participants treated with pembrolizumab was 10.6 months (range 1.1+, 16.5+) and 9.5 months (range 1.4+, 15.4+) for those in the placebo arm.

The adverse response profile reported in Study KEYNOTE-811 individuals receiving pembrolizumab matches the known pembrolizumab safety profile.

Adult patients with locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma should take 200 mg every 3 weeks or 400 mg every 6 weeks of pembrolizumab in conjunction with trastuzumab and chemotherapy.

 

Reference : https://www.fda.gov/

Check details here.

 

Take second opinion on gastric cancer treatment


Send Details

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Claudin18.2-targeted CAR-T cell therapy brings complete remission in advanced pancreatic cancer patient A case report
CAR T-Cell therapy

Claudin18.2-targeted CAR-T cell therapy brings complete remission in advanced pancreatic cancer patient : A case report

Claudin18.2-targeted CAR-T cell therapy has shown remarkable potential in treating advanced pancreatic cancer, as highlighted in a recent case report. This innovative approach led to complete remission in a patient with advanced disease, underscoring the promise of targeted immunotherapy. By leveraging the specific expression of Claudin18.2 on cancer cells, this therapy offers a precision-based treatment, heralding a new era in pancreatic cancer management with significant clinical implications.

What is the treatment after BCMA CAR T failed in RR multiple myeloma cases
CAR T-Cell therapy

What is the treatment after BCMA CAR T failed in R/R multiple myeloma cases?

For people with relapsed or refractory multiple myeloma, BCMA CAR T-cell therapy might not work. Other treatments, such as bispecific antibodies, other CAR T-cell therapies that target different antigens, and combination regimens with immunomodulatory drugs, proteasome inhibitors, and monoclonal antibodies, can still be used. OriCAR-017 is another immunotherapy that is under trial and is expected to be launched soon. Clinical trials offer experimental treatments, providing access to novel therapies. Tailored approaches based on patient-specific factors and emerging research are crucial for improving outcomes in this challenging scenario.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
We Are Online! Chat With Us!
Scan the code
Hello,

Welcome to CancerFax !

CancerFax is a pioneering platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies like CAR T-Cell therapy, TIL therapy, and clinical trials worldwide.

Let us know what we can do for you.

1) Cancer treatment abroad?
2) CAR T-Cell therapy
3) Cancer vaccine
4) Online video consultation
5) Proton therapy